MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 40IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-40-058
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for adverse local tissue reaction around prosthesis.Event is serious and is considered severe.Event is possibly related to device.Event is not related to procedure.Date of implant: (b)(6) 2010.Date of revision: (b)(6) 2022.Date of event: (b)(6) 2022.(left hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Operative note reviewed: on 31-aug-2022, the patient underwent a revision of a depuy synthes metal liner secondary to increasing pain and high cobalt blood levels compatible with metallosis.Upon entering the hip capsule, there was a small effusion.The synovium was gray with black staining compatible with metallosis.There was extensive coagulum behind the metal liner.The previously placed trunnion sleeve was attempted to be explanted from the native trunnion but was ¿cold welded¿ and could not be removed.Therefore, the decision was to clean polish and dry the trunnion sleeve and replace the same ceramic head.
Additional Manufacturer Narrative
Product complaint # (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ALTRX NEUT 40IDX58OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15694799
• Report Number: 1818910-2022-21532
• Device Sequence Number: 6706940
• Product Code: LPH
• UDI-Device Identifier: 10603295393351
• UDI-Public: 10603295393351
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K132959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1221-40-058
• Device Catalogue Number: 122140058
• Device Lot Number: 3030376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 10/21/2022; 12/01/2022
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 11/08/2022; 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORAIL AMT COLLAR SIZE 16; DLT TS CER HD 12/14 40MM +8.5; PINNACLE 100 ACET CUP 58MM; UNK HIP FEMORAL SLEEVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White